Standard Operating Procedure for Lyophilization Process

1) Purpose

The purpose of this SOP is to establish procedures for conducting lyophilization (freeze-drying) of pharmaceutical products to ensure product stability and quality.

2) Scope

This SOP applies to all personnel involved in the lyophilization process within the pharmaceutical manufacturing facility.

3) Responsibilities

3.1 Manufacturing Team

• Prepare lyophilization equipment and materials.
• Operate lyophilization cycles as per defined procedures.

3.2 Quality Assurance (QA) Team

• Verify compliance with lyophilization process parameters.
• Review lyophilization records and reports.

4) Procedure

4.1 Preparation of Lyophilization Process

1. Inspect lyophilizer and ensure it is clean and operational.
2. Prepare lyophilization trays and load product vials or containers.

4.2 Lyophilization Cycle

1. Set lyophilization parameters including shelf temperature, vacuum levels, and drying time.
2. Initiate and monitor lyophilization cycle.

4.3 Product Removal and Inspection

1. Complete lyophilization cycle as per defined protocols.
2. Remove dried product from lyophilizer and inspect for integrity.

4.4 Cleaning and Maintenance

1. Clean lyophilization equipment and maintain records of cleaning activities.
2. Perform preventive maintenance of lyophilizer as per schedule.

5) Abbreviations, if any

SOP: Standard Operating Procedure; QA: Quality Assurance

6) Documents, if any

• Lyophilization Process Parameters
• Lyophilization Cycle Records
• Cleaning and Maintenance Logs

7) Reference, if any

USP Chapter 1063: Lyophilization of Parenteral (7/93) Dosage Forms
ICH Q7: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients

8) SOP Version

Version 1.0